Principal Scientist, Chemiluminescent Immunoassay

Company Description Fapon is an industry-leading IVD platform organization that offers an unmatched product and service combination of innovative biomarkers and bioactive raw materials, and one-stop solutions of Open Instrument Systems and Reagents, with our mission to enable earlier disease identification and more timely, accurate, and affordable diagnosis. Nowadays, we have well-developed open platforms of the chemiluminescent analyzer, PCR system, SBS-based gene sequencer, etc. To complement the chemiluminescent systems solution Fapon established a CLIA reagent team in China to deliver highly competitive immunoassay solutions. In order to further improve the quality and performance of reagent development capabilities we plan to build a second reagent development in Munich, Germany with a leader based in Germany overseeing the management of both organizations. Therefore, we invite you to consider this unique opportunity to co-incubate and bring further technological breakthroughs with us. **Job Description**: We are seeking a highly experienced and talented principal scientist for our protein labeling and coupling area to support our German and Chinese reagent development teams. As the expert in this domain, you will be responsible for successfully developing and integrating new protein labeling and coupling technologies in our CLIA reagent development process. This position will require deep extensive problem-solving capabilities and solid communication skills across different teams. **Key Responsibilities*** - Support the German and Chinese reagent development teams to ensure the timely completion of products at projected costs within specified performance parameters. - Develop and improve protein labeling and coupling processes within CLIA reagents development - Establish and standardize labeling and coupling processes - Provide technical guidance and training to both teams and participate in problem-solving processes. - Participate in multifunctional project teams and collaborate across the organization at various levels, across functional groups and geographical locations - Ensure all FDA, ISO, and related quality and regulatory requirements are consistently met. **Qualifications**: - An advanced scientific degree in areas of life sciences, biochemistry, or other relevant areas - 12+ years of experience in protein labeling and coupling technologies, ideally in the CLIA reagent development industry - Experience in setting up a system for protein coupling process control and manufacturing scale-up - Innovative approach to new labeling and coupling technologies and a track record in problem-solving of critical issues during reagent development - Global experience participating in cross-functional teams - Practical experience in effective development processes, system establishment, and familiarity with ISO13485 - Experience in supporting and improving multiple CLIA reagents, ideally in the area of infectious diseases, myocardial diseases, tumors, hormones, and anemia. - Critical knowledge in process optimization and KPI development for proper troubleshooting techniques - Good communication and interaction skills ideally with different cultural background - Possess a broad knowledge of surrounding areas including quality, regulatory and compliance, and manufacturing **Personal Skills/Attributes**: - Critical thinker able to address complex situations and issues. Personally accountable and takes ownership. - Express abstract and controversial ideas clearly and effectively: - Acts decisively, holds position and challenges others appropriately. - Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals. Additional Information **About Fapon** Founded in 2001 and headquartered in Guangdong, China, Fapon Group is mainly engaged in product R&D and services of in vitro diagnostic (IVD), biological therapy, and precise diagnosis and treatment. With our core value of "foresee and prepare for what future demands", Fapon focuses on three major businesses: raw material solutions, IVD ecosystem platform service, and intelligent digital diagnosis and treatment. Based on the global industrial ecology, Fapon has established major production and sales (R&D) bases in Beijing, Shenzhen, Shanghai, the United States, Germany, India, and other locations throughout the world, forming a global R&D, production, marketing, and service network, with products being widely sold to 61 countries and regions. An equal opportunity employer, Fapon welcomes and encourages diversity in our workforce.